Nihon Kohden BSM-6000 User manual

Operator’s Manual

Bedside Monitor

BSM-6301/BSM-6501/BSM-6701

BSM-6000 series

BSM-6301A

BSM-6301K

BSM-6501A

BSM-6501K

BSM-6701A

BSM-6701K

0614-900685H

If you have any comments or suggestions on this manual, please contact us at: www.nihonkohden.com

Copyright Notice

The entire contents of this manual are copyrighted by Nihon Kohden. All rights are reserved. No part of this document may be reproduced, stored, or transmitted in any form or by any means (electronic, mechanical, photocopied, recorded, or otherwise) without the prior written permission of Nihon Kohden.

Trademark

The mark printed on the SD card that is used in this instrument is a trademark. The company name and model name are trademarks and registered trademarks of each company.

Contents

About this Manual.......................................................	1
Related Documentation...............................................	1
Intended Purpose........................................................	2
Precautions.................................................................	4
General Handling Precautions...............................	4
EMC Related Caution............................................	4
Other Caution.........................................................	6
Responsibility of the Manufacturer..............................	6
Conventions Used in this Manual and Instrument.......	7
Warnings, Cautions and Notes..............................	7
Text Conventions in this Manual.............................	7
Explanations of the Symbols in this Manual and
Instrument..............................................................	8
General Safety Information.......................................	11
Panel Description......................................................	13
MU-631R Main Unit.............................................	13
MU-651R/MU-671R Main Unit.............................	15
AY-631P/AY-633P/AY-651P/AY-653P/AY-660P/
AY-661P/AY-663P/AY-671P/AY-673P Input Unit....	17
AA-672P/AA-674P Smart Expansion Unit...........	19
Installation.................................................................	21
General................................................................	21
Grounding the Monitor....................................	22
Environment for External Instruments.............	22
Warnings and Cautions for Connecting the
Monitor to a Network.......................................	23
Inserting and Removing the Battery Packs..........	24
Inserting the Battery Pack...............................	24
Removing the Battery Pack.............................	25
Inserting and Removing the Input Unit.................	26
Inserting the Input Unit....................................	26
Removing the Input Unit.................................	26
Loading Recording Paper....................................	27
Turning the Monitor On or Off....................................	28
Turning the Monitor On........................................	28
Check Before Turning On the Power...............	28
Check After Turning On the Power and
During Monitoring...........................................	29
Power and Battery Status Indications.............	30
Battery Pack Handling and Operation.............	31
Charging the Battery Pack..............................	33
Monitor Status on Power Interruption...................	34
Turning the Monitor Off........................................	34
Check After or Before Turning the Power Off.. 34
Basic Operation.........................................................	35
Using the Hard Keys on the Bedside Monitor
Operator’s Manual BSM-6000

and Touch Screen................................................	35
Using the Remote Control....................................	35
Using the Mouse..................................................	35
Home Screen Description.........................................	36
Settings for the Home Screen..............................	37
Trendgraph on the Home Screen (Current
Trendgraph)..........................................................	38
OCRG.............................................................	38
Freezing Waveforms.............................................	38
Using Sleep Mode................................................	38
MENU Window Description.......................................	39
Changing Settings.....................................................	40
Administrator Settings..........................................	40
Changing Parameter Settings and Other
Settings................................................................	40
Changing Settings...........................................	40
Changing Settings on the VOLUME
Window...........................................................	41
Admitting a Patient/Discharging a Patient (Deleting
Data).........................................................................	42
Admitting a Patient...............................................	43
Discharging a Patient (Deleting Data)..................	44
Transport...................................................................	45
Warnings and Cautions for Transport..............	45
Alarms.......................................................................	47
Alarm Types and Levels.......................................	47
Alarm Control Marks............................................	48
Flow of Alarm Function........................................	49
Silencing/Suspending Alarms..............................	50
Silencing Alarms.............................................	50
Suspending Alarms.........................................	50
Canceling Technical Alarms.................................	53
Alarm Sound Volume...........................................	53
Alarm Recording..................................................	53
Alarm Setting.......................................................	53
Changing Vital Sign Upper/Lower Alarm
Limits...............................................................	55
Changing the Arrhythmia Alarm Settings........	57
Interbed Alarm.....................................................	58
Review Windows.......................................................	59
General................................................................	59
Event Bar........................................................	60
TREND Window...................................................	61
GRAPH 1, GRAPH 2, GRAPH 3 Page...........	61
TABLE 1, TABLE 2, TABLE 3 Page.................	62
NIBP TREND Page.........................................	63
	C.

HEMO Page....................................................	64
Registering the Acquired Data to the
Hemodynamics Table Window........................	64
LUNG TREND Page........................................	65
RECALL Window.................................................	66
ARRHYTH HISTORY Page.............................	66
ALARM HISTORY Window..................................	67
ALARM HISTORY Page..................................	67
FULL DISC Window.............................................	68
FULL DISC Page............................................	68
ST Window...........................................................	70
ST INTERVAL Page........................................	70
OCRG Window.....................................................	71
12 LEAD/12 LEAD ANALYSIS Windows...................	72
General................................................................	72
Performing 12 Lead ECG Interpretation.........	72
12 LEAD Window.................................................	74
Viewing the 12 Lead Analysis Result..............	74
DRUG/LUNG FUNCTION Windows..........................	76
DRUG Window.....................................................	76
LUNG FUNCTION Window..................................	78
Recording..................................................................	80
Recording Modes.................................................	80
When More than One Recording Modes is
Triggered.........................................................	80
Changing Recording Settings..............................	80
Selecting Recording Waveforms.....................	81
Changing Recording Speed............................	81
Selecting Recording Interval for Periodic
Recording........................................................	81
Turning Alarm Recording On or Off................	81
INTERBED Window..................................................	82
Registering/Removing Interbed Beds..................	82
Displaying the Interbed Bed Data........................	83
Interbed Alarm.....................................................	84
Settings Related to Interbed Alarm.................	84
Monitoring Parameters..............................................	85
ECG.....................................................................	85
Preparation.....................................................	85
Monitoring Arrhythmia.....................................	88
Changing ECG Settings..................................	90
Respiration...........................................................	97
Preparation.....................................................	97
Changing Respiration Settings.......................	98
CO2 ....................................................................	100
Preparation...................................................	101
Changing CO2 Settings.................................	104
Inspection of Measuring Accuracy................	106
SpO2 with Nihon Kohden Probes (AY-660P/

AY-661P/AY-663P/AY-671P/AY-673P).................	107
Silencing SpO2 Alarm....................................	108
Preparation...................................................	108
Changing SpO2 Settings...............................	110
SpO2 with Nellcor Probes (AY-651P/AY-653P)...	114
Silencing SpO2 Alarm....................................	115
Preparation...................................................	115
Changing SpO2 Settings...............................	117
SpO2 with Masimo Probes (AY-631P/AY-633P)..	120
Silencing SpO2 Alarm....................................	121
Preparation...................................................	121
Changing SpO2 Settings...............................	124
NIBP...................................................................	128
Preparation...................................................	128
Changing NIBP Settings...............................	130
Starting and Stopping NIBP Measurement...	132
IBP.....................................................................	136
Preparation...................................................	136
Connecting Cables to the Unit......................	136
Assembling the Transducer...........................	137
Adjusting Zero Balance.................................	138
The CHECK ZERO Page..............................	139
Changing IBP Settings..................................	139
Temperature.......................................................	144
Preparation...................................................	144
Using the Insulation Pad...............................	145
Changing Temperature Settings....................	145
BIS.....................................................................	147
Preparation...................................................	147
Changing the BIS Settings............................	150
Cardiac Output...................................................	153
Preparation...................................................	153
Measuring the Pulmonary Capillary Wedge
Pressure........................................................	154
Measuring Cardiac Output............................	155
Deleting the Data from the CO Table ...........	158
Adding the Acquired Data to the HEMO
Page of the TREND Window.........................	159
GAS...................................................................	160
Preparation...................................................	160
Changing Gas Settings.................................	160
Inspection of Measuring Accuracy................	164
O2 .......................................................................	165
Preparation...................................................	165
Changing O2 Settings....................................	166
Other Parameters...............................................	167
Screen Messages...................................................	169
Troubleshooting.......................................................	185
Monitoring..........................................................	185

C.	Operator’s Manual BSM-6000

Network..............................................................	185
Transport............................................................	186
Remote Control..................................................	187
Recording...........................................................	187
Printing...............................................................	187
ECG...................................................................	188
Respiration.........................................................	189
Impedance Method.......................................	189
Thermistor Method........................................	189
CO2 ....................................................................	190
Mainstream Method......................................	190
Sidestream Method.......................................	190
When Using Microcap® Monitor....................	191
SpO2 ..................................................................	191
When Using Nellcor/Masimo Pulse
Oximeter.......................................................	192
NIBP...................................................................	192
IBP.....................................................................	193
Temperature.......................................................	193
BIS.....................................................................	193
When Using BIS Processor/BISx..................	193
When Using BIS Monitor...............................	193
Cardiac Output...................................................	194
GAS...................................................................	194
When Using AG-920R Multigas Unit.............	194
When Using GF-110PA Multigas Unit or
GF-120PA Multigas/Flow Unit.......................	195
When Using GF-210R Multigas Unit or
GF-220R Multigas/Flow Unit.........................	196
When Using Dräger Medical Primus/
Fabius® Anesthesia Workstation...................	197
O2 ......................................................................	197
Ventilation...........................................................	197
TOF....................................................................	198
CCO...................................................................	198
When Using Vigilance Monitor......................	198
When Using PiCCO Monitor.........................	198
CCO/SvO2 .........................................................	199
FLOW/Paw.........................................................	199
When Using GF-110PA Multigas/Flow Unit.. 199
When Using GF-220R Multigas/Flow Unit....	199
EEG...................................................................	200
tcPO2/tcPCO2 ....................................................	201
Transmitter.........................................................	201
12 Lead ECG.....................................................	201
Maintenance............................................................	202
MU-631R, MU-651R and MU-671R Main Unit...	202
Cleaning and Disinfecting the Main Unit.......	202
Cleaning the Touch Screen...........................	203

Disposing of the Main Unit............................	204
WS-671P Recorder Module...............................	204
Cleaning the Thermal Head..........................	204
Cleaning the Sensors....................................	204
Disposing of the Recorder Module................	204
AY Series Input Unit and AA-672P/AA-674P
Smart Expansion Unit........................................	205
Cleaning and Disinfecting the Units..............	205
Disposing of the Units...................................	205
SB-671P Battery Pack.......................................	205
Battery Lifetime.............................................	205
Replacing the Batteries.................................	205
Disposing of Batteries...................................	205
RY-910P Remote Controller...............................	205
Cleaning and Disinfecting the Remote
Controller......................................................	205
Disposing of the Remote Controller..............	205
Replacing the Batteries.................................	205
Disposing of Batteries...................................	205
QF series Interface and IF series
Communication Cable........................................	205
Cleaning and Disinfecting the Interface and
Communication Cable...................................	205
Disposing of the Interface and
Communication Cable...................................	205
Leads, Cables and Cords...................................	206
Cleaning the Leads, Cables and Cords........	206
Disinfecting the Leads, Cables and Cords....	206
Disposing of Leads, Cables and Cords.........	206
Electrodes, Probes, Cuffs, Thermistors,
Transducers, Catheters and Other
Consumables.....................................................	206
Yearly Inspection................................................	206
Safety Information for Maintenance on
Optional Units....................................................	207
AG-920R, GF-110PA or GF-210R Multigas
Unit and GF-120PA or GF-220R Multigas/
Flow Unit.......................................................	207
AG-400R CO2 Unit........................................	207
AE-918P Neuro Unit.....................................	208
Specifications..........................................................	209
Measuring Parameters..................................	209
Influence on Measuring Accuracy by
Electrosurgery/Defibrillation/Electrostatic
Discharge......................................................	209
Display..........................................................	209
Alarm............................................................	210
Alarm Delay Time..........................................	211
ECG .............................................................	211

Operator’s Manual BSM-6000

C.

Respiration (Transthoracic impedance
pneumography).............................................	214
SpO2 .............................................................	214
Non Invasive Blood Pressure, NIBP.............	217
Multi Socket...................................................	218
Invasive Blood Pressure, IBP........................	218
Temperature..................................................	219
Carbon Dioxide, CO2 (Mainstream
method) ........................................................	219
Inspired Oxygen Fractional Concentration,
O2 ..................................................................	220
Cardiac Output, CO......................................	220
Respiration (Thermistor method)..................	221
Bispectral Index, BIS.....................................	221
ECG/BP Output.............................................	221
RGB Socket (when QI-631P or QI-671P is
connected)....................................................	222
RS-232C Socket (when QI-631P or
QI-671P is connected)..................................	222
Alarm Socket (when QI-632P or QI-671P
is connected).................................................	222
When WS-671P Recorder Module is
Connected.....................................................	222
When ZS-900P Transmitter is Connected.....	223
Gas...............................................................	223
Carbon Dioxide, CO2 (Sidestream method)..	226
FLOW/Paw....................................................	226
EEG..............................................................	227
Battery (SB-671P Battery Pack)...................	228
Power Requirement......................................	228
Clock Accuracy.............................................	228
Environment..................................................	228
Mechanical Strength.....................................	229
Electromagnetic Compatibility.......................	229
Safety Standard............................................	229
Dimensions and Weight (approximate).........	230
Electromagnetic Emissions...........................	231
Electromagnetic Immunity.............................	232
Recommended Separation Distances
between Portable and Mobile RF
Communications Equipment.........................	234
System Composition for EMC Test................	235
Factory Default Settings..........................................	236
Event Bar...........................................................	236
TREND Window.................................................	237
RECALL Window...............................................	240
FULL DISC Window...........................................	240
ST Window.........................................................	240
OCRG Window...................................................	241
C.

ADMIT Window..................................................	241
ALARM LIMITS Window....................................	242
Vital Signs Alarms.........................................	242
Arrhythmia Alarms........................................	245
DATE Window....................................................	245
VOLUME Window..............................................	246
DISPLAY Window...............................................	246
RECORD Window..............................................	246
ECG Window......................................................	247
RESP/CO2 Window............................................	248
SpO2 Window.....................................................	248
NIBP Window.....................................................	249
PRESS Window.................................................	250
TEMP Window...................................................	251
BIS Window........................................................	251
CO Window........................................................	251
GAS Window......................................................	252
O2 Window..........................................................	252
VENT Window....................................................	252
CCO Window.....................................................	253
FLOW/Paw Window...........................................	253
EEG Window......................................................	254
12 LEAD ANALYSIS Window.............................	255
DRUG Window...................................................	255
LUNG FUNCTION Window................................	257
INTERBED Window...........................................	257
Standard Accessories.............................................	258
MU-631RA/MU-651RA/MU-671RA Main Unit....	258
MU-631RK/MU-651RK/MU-671RK Main Unit....	258
Options/Consumables.............................................	259
Accessory Set....................................................	259
MU-631RA/MU-651RA/MU-671RA Main Unit....	260
MU-631RK/MU-651RK/MU-671RK Main Unit....	260
WS-671P Recorder Module...............................	261
Units and Modules.............................................	261
Network..............................................................	261
Interfaces for Connecting External
Instruments........................................................	262
Cart and Attaching Parts....................................	263
For ECG and Respiration (Impedance Method)
Monitoring..........................................................	263
For Respiration Monitoring (Thermistor
Method)..............................................................	264
For CO2 Monitoring (Mainstream Method).........	264
For SpO2 Monitoring...........................................	265
For NIBP Monitoring...........................................	266
For IBP Monitoring.............................................	267
For Temperature Monitoring...............................	268
For BIS Monitoring (Using the BIS Processor/
BISx)..................................................................	268
Operator’s Manual BSM-6000

For CO Monitoring..............................................	268
For O2 Monitoring...............................................	269
For CO2 Sidestream Monitoring.........................	269
For BIS Monitoring (Using the BIS Monitor).......	269
For Anesthetic Agent Monitoring........................	269
For FLOW/Paw Monitoring.................................	269
For EEG Monitoring...........................................	269
General Requirements for Connecting Medical
Electrical Systems......................................................	270

Operator’s Manual BSM-6000

C.

About this Manual

This Operator’s Manual describes the most common features and functions of the BSM-6301A/K, BSM6501A/K and BSM-6701A/K bedside monitors.

Related Documentation

The BSM-6301A/K, BSM-6501A/K and BSM-6701A/K Bedside Monitors come with the following manuals in addition to the Operator’s Manual.

Administrator’s Guide

Describes how to install the bedside monitor. It also explains about the password protected settings on the SYSTEM SETUP window and SYSTEM CONFIGURATION screen which only an administrator can change.

User’s Guide, Part I

Gives supplemental information on the operation of the bedside monitor.

User’s Guide, Part II

Describes the features and settings of the monitoring parameters.

Service Manual

Describes information on servicing the bedside monitor. Only qualified service personnel can service the bedside monitor.

Operator’s Manual BSM-6000

1

Intended Purpose

The Life Scope TR BSM-6301A/K, BSM-6501A/K and BSM-6701A/K bedside monitors are for one patient. The BSM-6301A/K bedside monitors have a 10.4 inch TFT color display, BSM-6501A/K have a 12.1 inch TFT color display, and BSM-6701A/K have a 15 inch TFT color display. All the monitors can display 15 waveforms on the screen.

The bedside monitors are to be installed near the patient. With the basic configuration of the system, ECG, respiration in impedance or thermistor method, SpO2, NIBP, IBP, temperature, CO2 and O2 of all hospital patients can be monitored and alarms are generated.* The monitor is designed so the operator can directly touch the screen from the operator position. The basic configuration of the system is the following units. This manual is based on this configuration.

* Essential performance in EMC standard.

WARNING

Do not use the same monitor for more than one patient at the same time. Do not connect different sensors from different patients to the same monitor.

WARNING

Do not diagnose a patient based only on data acquired by the bedside monitor. Overall judgement must be performed by a physician who understands the features, limitations and characteristics of the bedside monitor and by reading the biomedical signals acquired by other instruments.

•MU-631RA/RK, MU-651RA/RK, MU-671RA/RK main unit

•QI-631P, QI-632P, QI-634P, QI-671P, QI-672P interface

•AY series input unit

Input Unit Model

AY-631P

AY-633P

AY-651P

AY-653P

AY-660P*1

AY-661P*1

AY-663P*1

AY-671P

AY-673P

No. of MULTI sockets

1

3

1

3

1

1

3

Available parameters

RESP (Thermistor), CO2, SpO2, IBP,

RESP (Thermistor),

CO2, IBP

CO2, SpO2, IBP, TEMP,

using MULTI sockets

TEMP, BIS, CO, O2

BIS, CO, O2

No. of TEMP sockets

2

1

2

ECG measurement

Yes

No

Yes

using 10 electrodes

12 lead analysis

Yes

No

Yes

SpO2 probe

Masimo

Nellcor

Nihon Kohden

Dual SpO2

Yes*2

Yes*3

Yes*4

Yes*5

NIBP PWTT

No

Yes

measurement

Smart expansion unit

Analog ECG

Yes

No

Yes

Analog BP

HT output

*1 AY-660P, AY-661P and AY-663P input units are not available for BSM-6000A series.

*2 IF-925P communication cable is required.

*3 IF-919P communication cable is required.

*4 Dual SpO2 is available when the MULTI socket on the JA-694PA data acquisition unit is used.

*5 JL-500P1 or JL-500P2 SpO2 adapter is required.

• AA-672P/AA-674P smart expansion unit

• WS-671P recorder module

• SB-671P battery pack

Operator’s Manual BSM-6000

For simplicity, the model number suffixA/G/K is omitted in this manual.

NOTE:

•This monitor must be used by qualified medical personnel with a full knowledge of operating this monitor.

•Upgrade the main unit and each optional unit to the Nihon Kohden recommended software version. Only use the specified configuration of units. If more than one BSM-6000 series bedside monitor is used in the same facility, make sure the bedside monitors have the same software version. If BSM-6000 series monitors with different software versions are used together, correct system operation cannot be guaranteed.

•Only use Nihon Kohden parts and accessories to assure maximum performance from your instrument.

Operator’s Manual BSM-6000

3

Precautions

General Handling Precautions

•This device is intended for use only by qualified medical personnel.

•Only use Nihon Kohden approved products with this device. Use of non-approved products or in a non-approved manner may affect the performance specifications of the device. This includes, but is not limited to, batteries, recording paper, extension cables, electrode leads, input units and AC power.

•This device must receive expert, professional attention for maintenance and repairs. When the device is not functioning properly, it should be clearly marked to avoid operation while it is out of order.

•This device must not be altered or modified in any way.

EMC Related Caution

This equipment and/or system complies with IEC 60601-1-2 International Standard for electromagnetic compatibility for medical electrical equipment and/or system. However, an electromagnetic environment that exceeds the limits or levels stipulated in IEC 60601-1-2, can cause harmful interference to the equipment and/or system or cause the equipment and/or system to fail to perform its intended function or degrade its intended performance. Therefore, during the operation of the equipment and/or system, if there is any undesired deviation from its intended operational performance, you must avoid, identify and resolve the adverse electromagnetic effect before continuing to use the equipment and/or system.

The following describes some common interference sources and remedial actions:

1.Strong electromagnetic interference from a nearby emitter source such as an authorized radio station or cellular phone:

Install the equipment and/or system at another location. Keep the emitter source such as cellular phone away from the equipment and/or system, or turn off the cellular phone.

2.Radio-frequency interference from other equipment through the AC power supply of the equipment and/or system:

Identify the cause of this interference and if possible remove this interference source. If this is not possible, use a different power supply.

3.Effect of direct or indirect electrostatic discharge:

Make sure all users and patients in contact with the equipment and/or system are free from direct or indirect electrostatic energy before using it. A humid room can help lessen this problem.

4.Electromagnetic interference with any radio wave receiver such as radio or television: If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or system as far as possible from the radio wave receiver.

5.Interference of lightning:

When lightning occurs near the location where the equipment and/or system is installed, it may induce an excessive voltage in the equipment and/or system. In such a case, disconnect the AC power cord from the equipment and/or system and operate

Operator’s Manual BSM-6000

the equipment and/or system by battery power, or use an uninterruptible power supply.

6.Use with other equipment:

When the equipment and/or system is adjacent to or stacked with other equipment, the equipment and/or system may affect the other equipment. Before use, check that the equipment and/or system operates normally with the other equipment.

7.Use of unspecified accessory, transducer and/or cable:

When an unspecified accessory, transducer and/or cable is connected to this equipment and/or system, it may cause increased electromagnetic emission or decreased electromagnetic immunity. The specified configuration of this

equipment and/or system complies with the electromagnetic requirements with the specified configuration. Only use this equipment and/or system with the specified configuration.

8.Use of unspecified configuration:

When the equipment and/or system is used with the unspecified system configuration different than the configuration of EMC testing, it may cause increased electromagnetic emission or decreased electromagnetic immunity. Only use this equipment and/or system with the specified configuration.

9.Measurement with excessive sensitivity:

The equipment and/or system is designed to measure bioelectrical signals with a specified sensitivity. If the equipment and/or system is used with excessive sensitivity, artifact may appear by electromagnetic interference and this may cause mis-diagnosis. When unexpected artifact appears, inspect the surrounding electromagnetic conditions and remove this artifact source.

If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden representative for additional suggestions.

The CE mark is a protected conformity mark of the European Community. Products with the CE mark comply with the requirements of the Medical Device Directive 93/42/EEC.

BSM-6301 and BSM-6501 (JA-690PA/JA-694PA data acquisition unit, QE-910P BIS processor and QI-320PA wireless LAN station are not connected) comply with International Standard IEC 60601-1-2: 2001 and Amendment 1: 2004 which requires CISPR11, Group 1, Class B. Class B EQUIPMENT is equipment suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.

BSM-6301, BSM-6501 (JA-690PA/JA-694PA data acquisition unit, QE-910P BIS processor and QI-320PA wireless LAN station are connected) and BSM-6701 comply with International Standard IEC 60601-1-2: 2001 and Amendment 1: 2004 which requires CISPR11, Group 1, Class A. Class A EQUIPMENT is equipment suitable for use in industrial or light industrial establishments and commercial environment.

BSM-6301 and BSM-6501 (when QE-910P and ZS-900P are connected) are CLASS A

Operator’s Manual BSM-6000

5

equipment if the equipment complies with IEC 60601-1-2: 2001 36 201.1.5 in the countries which do not have national wireless rule.

In IEC 60601-1-2 Medical Electronic Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard: Electromagnetic compatibility-Requirements and test. Section 36. 202. 2 Radiated radio-frequency electromagnetic fields, PATIENT COUPLED EQUIPMENT and/or SYSTEMS applicable IMMUNITY test methods are under consideration at SC62A/ WG13. The 3 V/m IMMUNITY level may be inappropriate especially when measuring SpO2 because physiological signals can be much smaller than those induced by a 3 V/m electromagnetic field.

When measuring SpO2, various interference may produce false waveforms which look like pulse waveforms. SpO2 value and pulse rate may be measured from these false waveforms, causing the alarm to function improperly.

When installing the monitor, avoid locations where the monitor may receive strong electromagnetic interference such as radio or TV stations, cellular phone or mobile twoway radios.

Other Caution

United States law restricts this product to sale by or on the order of a physician.

Responsibility of the Manufacturer

Nihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one year from the date of delivery. However, consumable materials such as recording paper, ink, stylus and battery are excluded from the warranty.

NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period, provided these products are used as prescribed by the operating instructions given in the user’s guide, operator’s and service manuals.

This warranty does not apply to products that have been modified, disassembled, reinstalled or repaired without Nihon Kohden approval or which have been subjected to neglect or accident, damage due to accident, fire, lightning, vandalism, water or other casualty, improper installation or application, or on which the original identification marks have been removed.

Operator’s Manual BSM-6000

Conventions Used in this Manual and Instrument

Warnings, Cautions and Notes

Warnings, cautions and notes are used in this manual to alert or signal the reader to specific information.

WARNING

A warning alerts the user to possible injury or death associated with the use or misuse of the instrument.

CAUTION

A caution alerts the user to possible injury or problems with the instrument associated with its use or misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other property.

NOTE: A note provides specific information, in the form of recommendations, prerequirements, alternative methods or supplemental information.

Text Conventions in this Manual

•Names of hard keys on the bedside monitor are enclosed in square brackets: [Menu]

•Messages that are displayed on the screen are enclosed in quotation marks: “CHECK ELECTRODES”

•Names of items that are displayed on the screen are enclosed in angle brackets: <SENSITIVITY>

Operator’s Manual BSM-6000

7

Explanations of the Symbols in this Manual and Instrument

MU-631R/MU-651R/MU-671R Main Unit

Symbol

Description

Symbol

Description

“On” only for a part of instrument

Network socket

“Off” only for a part of instrument

Output terminal

Alternating current

Equipotential terminal

Battery charging

Attention, consult operator’s manual

Out of paper

Serial number

Record

Date of manufacture

Alarm silence

BIS processor/BISx

Attention, consult operator’s manual

Battery slot 1/Battery slot 2 (MU-631R only)

NIBP

ZS

ZS socket

NIBP interval

CSA mark*

NIBP start

MR unsafe*

NIBP stop

The CE mark** is a protected conformity mark of

the European Community. Products marked with

Menu

this symbol comply with the requirements of the

Medical Device Directive 93/42/EEC.

Home

Products marked with this symbol** comply

with the European WEEE directive 2002/96/EEC

Data input/output

and require separate waste collection. For Nihon

Kohden products marked with this symbol,

SD card slot

contact your Nihon Kohden representative for

disposal.

*The CSA mark and MR unsafe mark only apply to the MU-631RA/MU-651RA/MU-671RA.

**The CE mark and WEEE mark only apply to the MU-631RK/MU-651RK/MU-671RK.

AY Series Input Unit

Symbol

Description

Symbol

Description

Defibrillation-proof type CF applied part

Serial number

Output terminal

Date of manufacture

The CE mark is a protected conformity mark of

Attention, consult operator’s manual

the European Community. Products marked with

this symbol comply with the requirements of the

Medical Device Directive 93/42/EEC.

Operator’s Manual BSM-6000

AA-672P/AA-674P Smart Expansion Unit

Symbol

Description

Symbol

Description

Defibrillation-proof type CF applied part

Date of manufacture

Attention, consult operator’s manual

The CE mark is a protected conformity mark of

the European Community. Products marked with

Serial number

this symbol comply with the requirements of the

Medical Device Directive 93/42/EEC.

QI-631P Interface

Symbol

Description

Symbol

Description

Serial interface (RS-232C socket)

Attention, consult operator’s manual

External display (RGB socket)

QI-632P Interface

Symbol

Description

Symbol

Description

Input/output terminal (USB socket and Multi-link

Attention, consult operator’s manual

socket)

Output terminal (Alarm socket)

QI-634P Interface

Symbol

Description

Symbol

Description

Input/output terminal (USB socket and Multi-link

Attention, consult operator’s manual

socket)

QI-671P Interface

Symbol

Description

Symbol

Description

Input/output terminal (Multi-link socket)

External display (RGB socket)

Serial interface (RS-232C socket)

Attention, consult operator’s manual

Output terminal (Alarm socket)

QI-672P Interface

Symbol

Description

Symbol

Description

Input/output terminal (USB socket and Multi-link

Attention, consult operator’s manual

socket)

Operator’s Manual BSM-6000

9

WS-671P Recorder Module

Symbol

Description

Symbol

Description

Attention, consult operator’s manual

The CE mark is a protected conformity mark of

the European Community. Products marked with

Serial number

this symbol comply with the requirements of the

Medical Device Directive 93/42/EEC.

Date of manufacture

SB-671P Battery Pack

Symbol

Description

Symbol

Description

Recycle mark

Environmental protection use period: 10 years

Products marked with this symbol comply with

The CE mark is a protected conformity mark of

the European WEEE directive 2002/96/EEC

the European Community. Products marked with

and require separate waste collection. For Nihon

this symbol comply with the requirements of the

Kohden products marked with this symbol,

Medical Device Directive 93/42/EEC.

contact your Nihon Kohden representative for

disposal.

On screen

Symbol

Description

Symbol

Description

Alarm silence

Accessing to SD card

Alarm suspended

Checking SD card

All alarms off or vital sign alarm limit off

SD card failure

Non-paced

Adjust setting/Scroll data

QRS/pulse sync mark

Zoom in/Zoom out

Respiration sync mark

Left end/Right end

Battery status

@

Touch panel calibration

10	Operator’s Manual BSM-6000

General Safety Information

WARNING

Never use the monitor in the presence of any flammable anesthetic gas or high concentration oxygen atmosphere. Failure to follow this warning may cause explosion or fire.

WARNING

When the monitor is used with an electrosurgical unit (ESU), firmly attach the entire area of the ESU return plate. Otherwise, the current from the ESU flows into the electrodes of the monitor, causing electrical burn where the electrodes are attached. For details, refer to the ESU manual.

WARNING

Before defibrillation, all persons must keep clear of the bed and must not touch the patient or any equipment or cord connected to the patient. Failure to follow this warning may cause electrical shock or injury.

WARNING

When performing MRI test, remove all electrodes and transducers from the patient which are connected to this instrument. Failure to follow this warning may cause skin burn on the patient. For details, refer to the MRI manual.

WARNING

After attaching electrodes, probes and sensors on the patient and connecting cables to the bedside monitor, check that there is no error messages and the waveforms and numeric data are appropriately displayed on the screen. If there is an error message, or waveform or numeric data is not appropriate, check the electrodes, probes and sensor attachment, patient condition and settings on the bedside monitor and remove the cause.

WARNING

Never use the monitor in a hyperbaric oxygen chamber. Failure to follow this warning may cause explosion or fire.

WARNING

When performing defibrillation, discharge as far as possible from electrodes, patches and any gel, cream or medicine on the chest of the patient. If there is a possibility that the defibrillator paddle could touch these materials, remove them from the patient. If the defibrillator paddle directly contacts these materials, the discharged energy may cause skin burn to the patient.

WARNING

Do not perform defibrillation when the cables are located between the defibrillator paddles. The discharged energy may be insufficient.

WARNING

Do not allow the conductive part of the connector which is connected to the patient to contact other conductive parts including earth. This causes leakage current and incorrect measurement value and leads to wrong diagnosis.

WARNING

Do not use the same monitor for more than one patient at the same time. Do not connect different sensors from different patients to the same monitor.

WARNING

Do not leave the SD card near the patient or in reach of children.

Operator’s Manual BSM-6000

11

CAUTION

Only use Nihon Kohden specified electrodes, probes, transducers, thermistors and catheters. Otherwise, the maximum performance from the monitor cannot be guaranteed.

CAUTION

Make sure that the electrodes and cords attached to the patient are properly connected to the monitor. Otherwise, incorrect data may be displayed and lead to wrong diagnosis.

CAUTION

Turn off the power of mobile phones, small wireless devices and other devices which produce strong electromagnetic interference around a patient (except for devices allowed by the hospital administrator). Radio waves from devices such as mobile phones or small wireless devices may be mistaken as pulse waves and the displayed data may be incorrect.

CAUTION

Do not reuse disposable parts and accessories.

CAUTION

After the monitor power is turned on, parameterrelated alarms do not function until the parameters are monitored.

CAUTION

When admitting a new patient, first delete all data of the previous patient. Otherwise, the data of the previous patient and new patient will be mixed together.

CAUTION

If fluids are accidentally spilled into the monitor, take the monitor out of service and contact your Nihon Kohden representative. The monitor must be disassembled, cleaned, dried and tested for safety and function.

CAUTION

When the “CONNECTOR OFF” message appears on the screen, check that the connection cords are connected to the sockets properly. The patient cannot be monitored and the alarm does not function while this message is displayed.

CAUTION

When using a ZS-900P transmitter, the measurement values and displayed waveform on the bedside monitor and receiving monitor may differ due to timing delay of the display and other factors. Be careful when reading the value and waveform.

CAUTION

The ZS-900P transmitter can only transmit temperature data from 5 to 45°C (41 to 113°F). Be careful when reading the value.

CAUTION

The ZS-900P transmitter can only transmit CO2 data from 0 to 100 mmHg (0 to 13.3 kPa). When the transmitting data is out of this range, the receiving monitor displays it as 100 mmHg. Be careful when reading the value.

NOTE: Operate the monitor on battery power if you cannot confirm the grounding or wiring in your facility.

Using External Instruments

WARNING

When connecting an external instrument using an interface or communication cable to the monitor, some alarms and messages from the external instrument might not be displayed on the monitor. When the waveform or data is abnormal, check the alarm and message on the external instrument.

12	Operator’s Manual BSM-6000

Panel Description

MU-631R Main Unit

Front Panel

Alarm indicator

Red or yellow lamp blinks, or yellow or cyan lamps lights according to the alarm settings. Green lamp blinks in synchronization with the patient’s QRS or pulse.

Touch screen

Displays monitoring data. Touching a key or data on the screen changes the displayed screen and settings.

Power switch

Press and hold for more than one second to turn the monitor power on.

When turning the monitor power off, press and hold for more than three seconds.

Power lamp

Lights when the monitor power is turned on.

AC power lamp

Lights when the power cord is connected between the

AC SOURCE socket and AC outlet.

Handle

For carrying the monitor.

		Remote control sensor
Battery lamp 1		Receives an infrared signal
Indicates a battery		from the remote control.
status of the battery		Battery lamp 2
in the battery slot 1.		Indicates a battery status of
		the battery in the battery slot 2.

Silence Alarms key

Silences the alarm sound.

NIBP Interval key

Selects NIBP measurement mode. Pressing this key changes the mode.

NIBP Start/Stop key

Starts NIBP measurement in selected mode. Pressing the key during measurement stops measurement.

Menu key

Displays the MENU window.

Home key

Closes all opened windows and displays the home screen.

Record/Stop key (option)

Press to start or stop recording.

Error lamp (option)

Blinks when out of paper. Lights when the recorder door is open.

Speaker

For alarm and sync sound.

Left Side Panel

AY-673P

Input unit socket

Connects an AY series input unit.

Battery pack holder 1 (Battery slot 1)

For an SB-671P battery pack.

When the AY-673P input unit installed

AY-673P

AA-674P

When the AY-673P input unit and AA-674P smart expansion unit are installed

Operator’s Manual BSM-6000

13

Right Side Panel

SD card slot

For an SD card or program card.

Recorder module holder

For the WS-671P recorder module.

ZS socket

For the ZS-900P* transmitter.

Network socket

Connects to monitor network system

via the network separation unit.

Battery pack holder 2 (Battery slot 2)

For an SB-671P battery pack.

* ZS-900P transmitter is not available for BSM-6000A series.	When the WS-671P recorder module is installed

Rear Panel

Example shows the QI-631P and QI-632P interfaces installed.

QI-632P/QI-634P interface socket	QI-631P interface socket
Connects the QI-632P or QI-634P	Connects the QI-631P interface.
interface.

USB socket (QI-632P/QI-

Connects a mouse or bar code reader.

Multi-link socket (QI-632P/QI-634P)

Connects a QF interface, IF series communication cable or multi-link cable of an external unit.

Alarm socket (QI-632P)

Connects a YJ-672P nurse call cable.

RS-232C socket (QI-631P)

Not available.

RGB socket (QI-631P)

Outputs the RGB video signal. Connects to the slave display.

AC SOURCE power cord socket	Equipotential grounding terminal
For the AC power cord.	For an equipotential grounding lead.

14	Operator’s Manual BSM-6000

MU-651R/MU-671R Main Unit

Front Panel

Alarm indicator

Red or yellow lamp blinks, or yellow or cyan lamps lights according to the alarm settings. Green lamp blinks in synchronization with the patient’s QRS or pulse.

Touch screen

Displays monitoring data. Touching a key or data on the screen changes the displayed screen and settings.

Power switch

Press and hold for more than one second to turn the monitor power on.

When turning the monitor power off, press and hold for more than three seconds.

Power lamp

Lights when the monitor power is turned on.

AC power lamp

Lights when the power cord is connected between the

AC SOURCE socket and AC outlet.

Handle

For carrying the monitor.

			Silence Alarms key
			Silences the alarm sound.
			NIBP Interval key
			Selects NIBP measurement mode.
			Pressing this key changes the mode.
			NIBP Start/Stop key
			Starts NIBP measurement in selected
			mode. Pressing the key during
			measurement stops measurement.
			Menu key
			Displays the MENU window.
			Home key
			Closes all opened windows and
			displays the home screen.
			Record/Stop key (option)
			Press to start or stop recording.
		Remote control sensor	Error lamp (option)
			Blinks when out of paper.
		Receives an infrared signal
	Battery lamp 1		Lights when the recorder
	Indicates a battery	from the remote control.	door is open.
	status of the battery	Battery lamp 2	Speaker
	in the battery slot 1.	Indicates a battery status of
			For alarm and sync sound.
		the battery in the battery slot 2.

Left Side Panel

Input unit socket

Connects an AY series input unit.

Battery pack holder

For an SB-671P battery pack.

AY-673P

When the AY-673P input unit installed

AY-673P

AA-674P

When the AY-673P input unit and AA-674P smart expansion unit are installed

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15

Right Side Panel

SD card slot

For an SD card or program card.

ZS socket

For the ZS-900P* transmitter.

Network socket

Connects to monitor network system

via the network separation unit.

Recorder module holder

For the WS-671P recorder module.

* ZS-900P transmitter is not available for BSM-6000A series. When the WS-671P recorder module is installed

Rear Panel

QI-672P interface socket

Connects the QI-672P interface.

USB sockets

Connects a mouse or bar code reader.

Multi-link sockets

Connects a QF series interface, IF series communication cable or multi-link cable of an external unit.

QI-671P interface socket

Connects the QI-671P interface.

RS-232C socket

Not available.

Alarm socket

Connects a YJ-672P nurse call cable.

RGB socket

Outputs the RGB video signal. Connects to the dual display or slave display.

	AC SOURCE power cord socket	Equipotential grounding terminal
	For the AC power cord.
		For an equipotential grounding lead.

16	Operator’s Manual BSM-6000

AY-631P/AY-633P/AY-651P/AY-653P/AY-660P/AY-661P/AY-663P/AY-671P/AY-673P Input Unit

Front Panel

AY-660P: One TEMP socket, one MULTI socket, no ECG/BP OUT socket AY-631P/AY-651P/AY-661P/AY-671P: Two TEMP sockets, one MULTI socket AY-633P/AY-653P/AY-663P/AY-673P: Two TEMP sockets, three MULTI sockets

Example is AY-673P input unit.

MULTI socket

Connects to the connection cord of the parameter to be monitored (IBP, temperature, CO, CO2, O2, respiration by thermistor method, SpO2-2 (AY-661P/663P/671P/ 673P only) or BIS). The type of

parameter is automatically recognized.

NIBP socket

Connects to the air hose.

TEMP socket

Connects to the temperature probe cord.

SpO2 socket

Connects to the SpO2 connection cord.

ECG/RESP socket

Connects to the ECG connection cord.

ECG/BP OUT socket

Outputs 100 mmHg/V IBP waveform and

1 mV/V ECG waveform and heart rate trigger by using the YJ-910P or YJ-920P ECG/BP output cable. These analog signals can be used as the synchronization signal for other equipment, such as IABP.

WARNING

When performing defibrillation during cardiac output monitoring, never touch the CO connection cord. The discharged energy may cause electrical shock or injury.

CAUTION

When using the output signal from the monitor as the synchronization signal for other equipment such as an IABP (intra-aortic balloon pump) or defibrillator:

•Set the timing of the IABP by checking the waveform on the IABP screen.

•Check the condition of the bedside monitor at all times. The output signal may become unstable.

•Check that the delay time of the output signal is within the range of the connected equipment.

CAUTION

Only a Nihon Kohden defibrillator can use the output signal from the monitor as a synchronization signal. Check that the delay time of the output signal (heart rate trigger 20 ms maximum) is within the range of the connected defibrillator.

Operator’s Manual BSM-6000

17

NOTE:

•When using an IBP waveform as a synchronization signal for other equipment, connect the IBP line to the MULTI socket on the input unit. The IBP waveform that is used for the synchronization signal depends on the “IBP ANALOG OUT” setting in the SYSTEM SETUP window.

-When “IBP ANALOG OUT” is set to “FIXED POSITION”:

The IBP line connected to the top MULTI socket on the input unit is used.

-When “IBP ANALOG OUT” is set to “HIGHEST PRIORITY LABEL” :

When more than one IBP waveform is acquired, the IBP waveform of the highest priority label is used.

IBP label priority:

ART > ART2 > RAD > DORS > AO > FEM > UA > LVP > P1 > P2 > P3 > P4 > P5 > P6 > P7

•Analog ECG, analog BP and heart rate trigger output are not available when an AY-660P input unit is used.

•The output signal from the ECG/BP OUT socket may become unstable in the following conditions.

-Electrode is dry or detached.

-Electrode lead is damaged or disconnected from the electrode.

-Electrode lead is pulled.

-AC interference or EMG noise superimposed.

-Air bubbles or blood clog in the circuit for monitoring IBP.

-Cord or cable is disconnected or damaged.

•All instruments which are to be connected to the ECG/BP OUTPUT socket must use a YJ910P or YJ-920P ECG/BP output cable and comply with the IEC 60601-1 safety standard for medical equipment.

Left Side Panel

When the side panel is removed

Side panel

Smart expansion unit socket

Remove to attach an AA-672P or AA-674P

Connects an AA-672P or AA-674P smart expansion unit.

smart expansion unit.

18	Operator’s Manual BSM-6000

Right Side Panel

Tabs

Match the tabs on the input unit to the slots on the bedside monitor.

Rear Panel

Lock release lever

Lift up the lever to remove the input unit from the bedside monitor.

Input unit socket

For connecting a bedside monitor.

AA-672P/AA-674P Smart Expansion Unit

Front Panel
AA-672P	AA-674P
	MULTI socket
	Connects to the connection cord of
	the parameter to be monitored
	(IBP, temperature, CO, CO2, O2,
	respiration by thermistor method,
	SpO2-2 (AY-661P/663P/671P/
	673P only) or BIS). The type of
	parameter is automatically recognized.

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19

Right Side Panel

Connector

Connects an AY-631P, AY-633P, AY-651P, AY-653P,

AY-661P, AY-663P, AY-671P or AY-673P input unit.

20	Operator’s Manual BSM-6000

Installation

General

The monitor must be installed by qualified personnel. Details are in theAdministrator’s Guide.

WARNING

Only use the provided power cord. Using other power cords may result in electrical shock or injury to the patient and operator.

WARNING

When several medical instruments are used together, ground all instruments to the same onepoint ground. Any potential difference between instruments may cause electrical shock to the patient and operator.

WARNING

Connect only the specified instrument to the monitor and follow the specified procedure. Failure to follow this warning may result in electrical shock or injury to the patient and operator, and cause fire or instrument malfunction.

WARNING

•Do not install the monitor and optional units above the patient.

•Only use the specified tools or equipment when installing the monitor and units. Failure to follow this warning may result in the monitor or unit falling and injuring the patient.

CAUTION

Only use the specified stand, cart or equipment for installing the monitor and instruments. Using nonspecified equipment may result in the instruments falling and causing injury.

CAUTION

When not using the specified cart, carefully set the monitor to prevent it from falling off or tipping over.

CAUTION

Before connecting or disconnecting instruments, make sure that each instrument is turned off and the power cord is disconnected from the AC socket. Otherwise, the patient or operator may receive electrical shock or injury.

Make sure that there is more than 5 cm of space between the monitor and the wall for adequate ventilation. When the monitor is surrounded, make sure that there is about 10 cm of space above the monitor for ventilation so that the operating temperature does not exceed 40°C (104°F).

10 cm

5 cm Rear Panel

5 cm

Side Panel

Operator’s Manual BSM-6000

21

Grounding the Monitor

When more than one electrical instrument is used, there may be electrical potential difference between the instruments. The potential difference between the instruments may cause current to flow to the patient connected to the instruments, resulting in electrical shock (micro shock).

When equipotential grounding is required, connect the equipotential ground terminal on the instrument to the equipotential ground terminal on the wall (equipotential grounding system) with the equipotential grounding lead (potential equalization conductor).

NOTE:

•For details on connecting an external instrument to the monitor, contact your Nihon Kohden representative.

•Leakage current may increase when interconnecting many medical instruments to the monitor.

Environment for External Instruments

Use external instruments in the following environment.

Medically-used room

Non-medically used room

Patient Environment

Outside the Patient Environment

BSM-6301/6501/6701

Interface

QI-631P

Sub display

(For MU-631R)

(IEC 60601-1 complied or

using the isolation transformer

Interface

Sub display

complied to IEC 60601-1)

QI-671P

(IEC 60601-1 complied or

(For MU-651R/671R)

using the isolation transformer

Multigas unit

complied to IEC 60601-1)

GF-110PA/210R*

Multigas/Flow unit

GF-120PA*/220R*

Neuro unit

AE-918P*

Interface

Interface

QI-632P/634P

(For MU-631R)

QF series

QI-672P

Communication

(For MU-651R/671R)

cable

IF series

External

instruments

(IEC 60601-1 complied)

External

instruments

(IEC 60601-1 complied)

Main unit

MU-631R/

671R/651R

Mouse

Bar code reader

Input unit

AY-660P*

Remote controller

RY-910PA

Input unit

AY-631P/633P

Smart

AY-651P/653P

expansion unit

AY-661P*/663P*

AA-672P/674P

AY-671P/673P

Recorder

module

WS-671P

Transmitter

ZS-900P

Hyper isolation

Central monitor

transformer

Network printer

QW-100Y

(IEC xxx complied)

Wireless LAN

(HIT-100)

station

QI-320PA

* These units are not available for BSM-6000A series.

22	Operator’s Manual BSM-6000

Warnings and Cautions for Connecting the Monitor to a Network

WARNING

Install all network devices, including printer and hubs, outside the patient environment (IEC 60601- 1-1). If they are installed inside the patient environment, the patient or operator may receive electrical shock or injury. For installation, contact your Nihon Kohden representative.

WARNING

Check the software version number of the monitor before connecting it to the network. Different software versions have different communication methods. More than one communication method in a network may cause communication failure. For details, refer to the Network and System Installation Guide.

WARNING

Connect the monitor to network as specified. Otherwise the patient and operator may receive electrical shock or injury. To connect the network, contact your Nihon Kohden representative.

WARNING

In a network where this monitor is connected, connect only the specified instruments. Unspecified instruments may cause electrical shock or injury to the patient and operator or cause instrument malfunction, instrument stop, or data loss.

WARNING

Do not use a damaged network cable. The patient or operator may receive electrical shock when the damaged part is touched.

CAUTION

When the monitor is connected to a central monitor network, set the Bed Name (Bed ID) and Group Name on the monitor. Otherwise, the default settings are used for the bed name and group name and the bed may be incorrectly identified on the central monitor.

CAUTION

The network must be managed by the network administrator. Make sure that each monitor in the network has a different IP address. Otherwise, data communication cannot be performed properly. When adding a monitor to an already operating network, set the IP address on the monitor before connecting the monitor to the network.

Operator’s Manual BSM-6000

23